Devices

Disclose ‘Locked’ Hearing Aids: Members of Congress

A bipartisan group of four senators and 11 members of the House is calling on FDA to strengthen protections for consumers with hearing loss by considering ways to inform them if they are purchasing so-called locked hearing aids. A letter to FDA commissioner Robert Califf says some hearing aid manufacturers use proprietary or “locked” software that can prevent consumers from having their hearing aids repaired unless they use the original device manufacturer or network-affiliated clinic.

“If the consumer has moved, is traveling when the device breaks, or the company has gone out of business, they may be left without a fully functioning hearing aid or have to purchase a new one,” the lawmakers write. “Because of a lack of disclosure requirements, many consumers are unaware of these possible restrictions when purchasing these costly devices.”

The letter was spearheaded by Rep. Kevin Mullin (D-CA) and Sen. Elizabeth Warren (D-MA). They are asking that, at a minimum, FDA inform consumers by requiring a disclaimer on the hearing aid label about whether it contains proprietary software and must be repaired or adjusted by the original manufacturer or network-affiliated clinic. The lawmakers say the policy would not prohibit the use of proprietary hearing aid software, but would help ensure that the consumer is notified in writing of the existing parameters.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome